Some rapid antigen tests, marketed to be carried in your suitcase for self-testing before returning from a holiday, are illegal. That is according to the MHRA (Medicines and Healthcare products Regulatory Agency).
The government has known about the issue for months but has not prevented travellers from using them to enter the UK.
While the tests are legal if used by a trained clinician they do not all have the approval that they need to be used as self-tests by the public.
These tests, also known as lateral flow, can cost as little as £20. They are very similar to the NHS kits provided for free in the UK, but the NHS tests are not permitted for travel.
While the NHS test has been approved for unsupervised home use by the MHRA, some lateral flow tests, including those made by one of the firms on BA.com’s list of test providers and two on Jet2.com’s, are not compliant with the legislation.
Cheap Covid tests from airlines
One major supplier, Excalibur, whose tests are listed for just £19.50 on BA.com and Jet2.com, said that the tests available through its ‘partners’ (presumably BA and Jet2) were compliant with the rules.
However, we bought a test from Excalibur after clicking through from British Airways and the instructions detailed that the test kit provided was designed for ‘swabs taken by a trained individual from members of the public’. It didn’t have the code that shows that it has been approved for self-testing.
Another provider, Living Care, whose kits are available for £25 through Jet2.com, admitted that its tests also did not have the right code for a self-test.
Is my lateral flow self-test illegal?
The MHRA warned in May that some tests, which may only have received approval for professional use by a clinician, were being wrongfully sold for self-testing.
If you can take a test yourself and get the result within minutes, without having to send it to a lab, then it should have been certified by what’s known as a ‘notified body’.
You can tell whether a self-test is compliant because it has a 4-digit number after the CE mark – usually 0123.
Excalibur and Living Care argue that their tests are suitable for self-testing but when we checked at the end of September neither had the required 4-digit code. Therefore, even if the tests are effective to use at home, they are illegal because they do not have the code to indicate they are compliant to the public.
Until the law changed in July most Covid tests did not need any kind of prior approval before being sold. All they needed was the official CE mark, or equivalent, which means that the manufacturer has self-declared that they meet the required standard. But the exception has always been unsupervised tests ‒ i.e. those without any involvement from a clinician and where you don’t have to send them to a laboratory.
These have always needed approval from a ‘notified body’ before they can be sold. This is because there’s evidence of higher false negative results from tests without any involvement from a clinician.
Testing firms respond
Excalibur told us that the tests available when you click through to its website from BA and Jet2.com do meet all the legal requirements for self-testing. It said that a printing error on the packaging of its tests meant that the correct code wasn’t shown. It also said that it was updating the instructions but that they did not imply that it was a professional-use test.
It added: ‘All tests will have the required CE mark displayed appropriately going forward. We have informed the regulator MHRA and this does not affect the integrity or quality of the test in any way.’
Living Care said that its tests are compliant when used at its assisted testing sites. However, it did say that it would now be using a new test that is compliant with self-testing legislation.
While we don’t have any reason to believe that the two companies’ tests were inadequate, it is crucial that customers can be confident that the tests they buy comply with legal requirements.
Tui tests and others cleared for use
We reported in June that the cheap tests sold through Tui, from its provider Chronomics, originally lacked the required 4-digit code, as did those sold by another major provider, Qured. However, both firms took steps at the time to make sure they did comply with the regulations.
This month we contacted five more firms selling lateral flow self-tests through links on airline websites to ask if they complied. Collinson, Medic Spot and Prenetics, who also partner with British Airways, all said that their tests comply with the regulations.
Contact us at firstname.lastname@example.org if you do purchase a lateral flow kit for self-testing that doesn’t have the required 4-digit code after the CE Mark.
Can you use these lateral flow tests to enter the UK?
We asked the government in May, and on several occasions since, whether travellers would be stopped from entering the country if they’d used tests which didn’t comply with the regulations.
It hasn’t replied and we haven’t heard of anybody being stopped for using tests without the right code.
Despite this, we recommend that travellers only use tests that they’re sure comply with the legislation.
The advice from the MHRA on gov.uk says: ‘If a lateral flow antigen test is marketed for self-testing, but does not have a 4-digit identifier number next to the CE, CE UKNI or UKCA mark symbol on the packaging, it is not compliant with the regulations required for self-testing.’
The government has said that this advice will also be added to the guidance for travellers entering the UK, which currently only stipulate how accurate the tests need to be (the ‘sensitivity’ and ‘specificity’.)
Tests available through airlines
Both BA.com and Jet2 list several providers of both lateral flow tests and PCR tests. Clicking through to buy a test from the airlines’ website is often a good idea as they can provide discounts to customers. However, it’s important to check that the test meets your destination’s requirements.
British Airways said that it had received assurances from Excalibur that its tests are certified for self-use. Jet2 has not yet responded to a request for comment.
Easyjet, Ryanair, Tui and other airlines also provide links to test providers, with discounts. See more about how to get a cheap Covid test here.
Do I need a lateral flow test for my trip?
The requirement to take a lateral flow test before departure to the UK is being scrapped from 4 October.
However, these tests will still be important as, from the end of the month, the requirement to take a PCR test on day 2 after arriving in England from abroad will also be removed for most people. Instead, arrivals will need to buy and take a lateral flow test. It’s unclear whether these tests will need to be supervised or whether they can be taken at home.
There has been concern as to whether companies have the capacity to produce the number of tests that are likely to be needed, as it’s not permitted to use the free tests available through the NHS.